Quality Engineer

An established and growing medical device manufacturer is seeking a Quality Engineer to join its expanding team. This is an excellent opportunity for an experienced quality professional who enjoys a hands-on role and wants to play a key part in maintaining compliance standards, supporting audits, and driving continuous improvement. The successful candidate will join a well-established quality team and work in an environment that combines accountability, autonomy, and genuine career development opportunities.

As the business continues to expand into new markets and introduce innovative products, there is significant potential for progression for individuals who demonstrate strong performance and ambition.

Reporting into the Quality leadership team, you will be responsible for supporting the maintenance and effectiveness of the Quality Management System and ensuring compliance with applicable regulatory requirements.

Responsibilities:

• Conducting internal quality system audits and compliance assessments.
• Supporting external inspections, certification audits, and customer audits.
• Preparing audit reports and tracking corrective actions through to completion.
• Evaluating corrective and preventive actions (CAPAs) to ensure effectiveness.
• Reviewing quality and compliance documentation against regulatory requirements.
• Supporting investigations into non-conformances and driving root cause analysis.
• Verifying that quality processes remain aligned with relevant industry standards and regulations.
• Working closely with cross-functional teams to promote continuous improvement initiatives.
• Providing clear and professional communication during customer and regulatory interactions.

Experience/qualifications:

• Minimum of 3 years' experience in a similar role within a medical device/highly regulated quality environment.
• Practical experience working with ISO 13485.
• Experience with either MDSAP or EU MDR requirements.
• Previous experience participating in or conducting quality audits.
• Strong understanding of quality management systems and compliance processes.
• Excellent written and verbal communication skills.
• Ability to manage priorities and work with minimal supervision.
• Eligibility to work in the UK without sponsorship requirements.

This is an opportunity to join a genuinely growing organisation offering a supportive team environment, genuine autonomy, and excellent opportunities for career development. You'll work across a broad range of quality and regulatory activities while benefiting from flexible working arrangements and a competitive benefits package.

If you have experience with ISO 13485 and MDSAP or MDR, and you're looking for a role where you can contribute to a growing organisation while developing your own career, then please apply for immediate consideration.